Postoperative PainNCT02660918
Decreasing Postoperative Pain Following Endometrial Ablation
A study testing Bupivacaine and Normal Saline in people with Postoperative Pain, run by Christiana Care Health Services at 1 site in United States.
Trial summary
To determine whether paracervical injection of long acting local anesthesia decreases postoperative pain following endometrial ablation under general anesthesia. Read more about this study
- Who is it for?
- Ages 30 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- Bupivacaine and Normal Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 84 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2016to Mar 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 55 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Premenopausal women
- English as primary language
- undergoing outpatient endometrial ablation at the Christiana Hospital Surgical Center
- Indication of menorrhagia
- Inication of abnormal uterine bleeding
- Indication of thickened endometrium.
Who cannot join
- Known malignancy
- weight less than 50 Kg
- amide allergy
- history of chronic pain
- cardiac arrhythmia
- dilaudid/codeine allergy
Show all 11Show fewer
- history of opioid use
- inability to take opioids by mouth
- uterine anomaly
- previous endometrial ablation
- primary language other than English.
Trial locations and contacts
1 site in 1 country.
United States1 site
Christiana Care Health System
Newark, Delaware, 19713
About this study
Official title: Decreasing Postoperative Pain Following Endometrial Ablation: A Randomized Controlled Trial
To determine whether paracervical injection of long acting local anesthesia decreases postoperative pain following endometrial ablation under general anesthesia.
Read the detailed description
Destruction of the endometrial lining to control bothersome uterine bleeding has been implemented since 1937. Currently there are various different 'second generation' energy sources to avert such bleeding, five of which are now approved in the United States. These 5 second generation devices include: Thermachoice/Cavaterm, which use high temperature fluid within a balloon; Microsulis, which applies microwaves; Novasure, which uses bipolar energy; Hydrothermablator, which uses free fluid at high temperatures; ELITT, which uses laser thermotherapy; and HerOption, which uses cryoablation. Patient selection for endometrial ablation is crucial, as it is intended for premenopausal women with normal uterine cavities and no desire for future fertility that are affected by heavy menstrual bleeding. Since the introduction of the initial 'second generation' device in 1997 these modalities have overtaken the industry mostly due to their ease of use and shorter operative times. Regardless, a Cochrane review finds insufficient evidence to prove superiority of these newer modalities over the traditional 'gold standard' resectoscopic technique.
Endometrial ablation has been demonstrated in a variety of settings including outpatient surgical centers as well as physician's offices. Evidence suggests that microwave endometrial ablation under local anesthesia is a safe and acceptable practice. Very often, when endometrial ablation is performed as an outpatient procedure, patients are pre-medicated and then receive a paracervical injection of local anesthesia to control pain intraoperatively. When endometrial ablations are performed as an outpatient procedure through a surgical center, a variety of anesthesia techniques are employed depending on the infrastructure and human and institutional resources available. These techniques may vary from conscious sedation to general anesthesia, all of which have been proven to be acceptable methods.
In this center endometrial ablations are performed as an outpatient procedure under general anesthesia with a variety of induction techniques and intraoperative pain management practices. According to physician preference, patients may receive an additional paracervical injection of local anesthetic before the procedure, immediately after, or not at all. To date, there are no studies evaluating the efficacy of local anesthetic in addition to general anesthesia for patients receiving endometrial ablation to guide physician practice. The purpose of this study is to evaluate the efficacy of local anesthetic, in addition to general anesthesia, in our large, community-based patient population, in meaningfully decreasing postoperative pain.
- Conditions
- Postoperative Pain
- Being tested
- Bupivacaine, Normal Saline
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BupivacaineDrug
Also called Marcaine, Sensorcaine
Paracervical injection of 20 mL 0.25% Bupivacaine at the completion of the procedure
Normal SalineOther
Equal volume injection of normal saline with the same paracervical technique
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Women undergoing endometrial ablation that meet the eligibility criterial will receive a standardized paracervical injection of Bupivacaine 20 mL 0.25% at the completion of the procedure. Receives: Drug: Bupivacaine |
| Control | Placebo comparator | Women undergoing endometrial ablation that meet the eligibility criterial will receive an equal volume standardized paracervical injection of Normal Saline at the completion of the procedure. Receives: Other: Normal Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Pain Score
Pain will be assessed using a 10 point visual analog scale. On the scale 0 represented no pain and 10 represented the highest pain level. Eligibility for analgesia was available for patients who reported pain higher than 5 out of 10 on the scale.
Pain levels were assessed by trained nursing staff blinded to the study. Lower numbers on the 10 point scale represented a positive outcome.
Patients
Measured: Immediate postoperatively through 8 hours post operation.
Intraoperative Total Blood Loss
Amount of operative blood lost measured in milliliters
Measured: Intraoperative
Remaining Tylenol Tablets With Codeine Not Taken at the End of Day 1 Following Discharge
All patients were given 10 tablets of Tylenol with codeine upon discharge for pain. This Outcome measure details the remaining number of tablets after day 1.
Measured: Postoperative
Secondary outcomes (6)
Occurrence of Intraoperative Complication
This represents any unanticipated complication related to the endometrial ablation.
Measured: During Surgery
Postoperative Complication
Any unanticipated complication related to the endometrial ablation.
Measured: 1 Day Postoperative
Postoperative Opioid Administered Following the Procedure But Prior to Discharge.
Narcotic medications administered in the recovery area before the patient was discharged from the Surgicenter.
Measured: Predischarge from hospital
Postoperative Toradol
Data was collected on whether or not the patient received Toradol following the endometrial ablation. Toradol is a non-narcotic pain medication.
Measured: Postoperative
Postoperative Anti-emetic
Data was collected on any nausea medicine administered following the endometrial ablation.
Measured: Postoperative
Time Between Recovery Initiation and Discharge
Time between arrival to the recovery room after surgery and discharge to home
Measured: hours between recovery initiation and discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2016 (estimated)
- Study startApr 2016
- Primary completionMar 2017
- Study completionMar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Christiana Care Health Services
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jordan Klebanoff, Christiana Care Health Services
- Investigators
- Jordan Klebanoff, MD, Principal investigator, Christiana Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02660918
- Sponsor's protocol ID
- 35179
- Status last verified
- Aug 2019
- First submitted
- 19 Jan 2016
- Last updated
- 28 Aug 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Fergusson RJ, Lethaby A, Shepperd S, Farquhar C. Endometrial resection and ablation versus hysterectomy for heavy menstrual bleeding. Cochrane Database Syst Rev. 2013 Nov 29;(11):CD000329. doi: 10.1002/14651858.CD000329.pub2.
PubMed 24288154Glasser MH, Heinlein PK, Hung YY. Office endometrial ablation with local anesthesia using the HydroThermAblator system: Comparison of outcomes in patients with submucous myomas with those with normal cavities in 246 cases performed over 5(1/2) years. J Minim Invasive Gynecol. 2009 Nov-Dec;16(6):700-7. doi: 10.1016/j.jmig.2009.06.023.
PubMed 19896596Wallage S, Cooper KG, Graham WJ, Parkin DE. A randomised trial comparing local versus general anaesthesia for microwave endometrial ablation. BJOG. 2003 Sep;110(9):799-807.
PubMed 14511961
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Decreasing Postoperative Pain Following Endometrial Ablation: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02660918
- Acronym / sponsor ID
- 35179
- Conditions
- Postoperative Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Christiana Care Health ServicesUniversity, hospital or other
- Study start
- Apr 2016
- Primary completion
- Mar 2017 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 21 Jan 2016 (estimated)
- Results
- Posted 28 Aug 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To determine whether paracervical injection of long acting local anesthesia decreases postoperative pain following endometrial ablation under general anesthesia.
Detailed description
Destruction of the endometrial lining to control bothersome uterine bleeding has been implemented since 1937. Currently there are various different 'second generation' energy sources to avert such bleeding, five of which are now approved in the United States. These 5 second generation devices include: Thermachoice/Cavaterm, which use high temperature fluid within a balloon; Microsulis, which applies microwaves; Novasure, which uses bipolar energy; Hydrothermablator, which uses free fluid at high temperatures; ELITT, which uses laser thermotherapy; and HerOption, which uses cryoablation. Patient selection for endometrial ablation is crucial, as it is intended for premenopausal women with normal uterine cavities and no desire for future fertility that are affected by heavy menstrual bleeding. Since the introduction of the initial 'second generation' device in 1997 these modalities have overtaken the industry mostly due to their ease of use and shorter operative times. Regardless, a Cochrane review finds insufficient evidence to prove superiority of these newer modalities over the traditional 'gold standard' resectoscopic technique.
Endometrial ablation has been demonstrated in a variety of settings including outpatient surgical centers as well as physician's offices. Evidence suggests that microwave endometrial ablation under local anesthesia is a safe and acceptable practice. Very often, when endometrial ablation is performed as an outpatient procedure, patients are pre-medicated and then receive a paracervical injection of local anesthesia to control pain intraoperatively. When endometrial ablations are performed as an outpatient procedure through a surgical center, a variety of anesthesia techniques are employed depending on the infrastructure and human and institutional resources available. These techniques may vary from conscious sedation to general anesthesia, all of which have been proven to be acceptable methods.
In this center endometrial ablations are performed as an outpatient procedure under general anesthesia with a variety of induction techniques and intraoperative pain management practices. According to physician preference, patients may receive an additional paracervical injection of local anesthetic before the procedure, immediately after, or not at all. To date, there are no studies evaluating the efficacy of local anesthetic in addition to general anesthesia for patients receiving endometrial ablation to guide physician practice. The purpose of this study is to evaluate the efficacy of local anesthetic, in addition to general anesthesia, in our large, community-based patient population, in meaningfully decreasing postoperative pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Drug: BupivacaineWomen undergoing endometrial ablation that meet the eligibility criterial will receive a standardized paracervical injection of Bupivacaine 20 mL 0.25% at the completion of the procedure. |
| Control | Placebo comparator | Other: Normal SalineWomen undergoing endometrial ablation that meet the eligibility criterial will receive an equal volume standardized paracervical injection of Normal Saline at the completion of the procedure. |
Who may qualify
- Ages
- 30 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Premenopausal women
- English as primary language
- undergoing outpatient endometrial ablation at the Christiana Hospital Surgical Center
- Indication of menorrhagia
- Inication of abnormal uterine bleeding
Key exclusion criteria (11 listed)
- Known malignancy
- weight less than 50 Kg
- amide allergy
- history of chronic pain
- cardiac arrhythmia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BupivacaineAlso: Marcaine, SensorcaineParacervical injection of 20 mL 0.25% Bupivacaine at the completion of the procedure | Drug | Treatment |
| Normal SalineEqual volume injection of normal saline with the same paracervical technique | Other | Control |
Primary outcome
Postoperative Pain Score
Time frame: Immediate postoperatively through 8 hours post operation.
Pain will be assessed using a 10 point visual analog scale. On the scale 0 represented no pain and 10 represented the highest pain level. Eligibility for analgesia was available for patients who reported pain higher than 5 out of 10 on the scale. Pain levels were assessed by trained nursing staff blinded to the study. Lower numbers on the 10 point scale represented a positive outcome. Patients
Intraoperative Total Blood Loss
Time frame: Intraoperative
Amount of operative blood lost measured in milliliters
Remaining Tylenol Tablets With Codeine Not Taken at the End of Day 1 Following Discharge
Time frame: Postoperative
All patients were given 10 tablets of Tylenol with codeine upon discharge for pain. This Outcome measure details the remaining number of tablets after day 1.
6 secondary outcomes
Occurrence of Intraoperative Complication
Time frame: During Surgery
Postoperative Complication
Time frame: 1 Day Postoperative
Postoperative Opioid Administered Following the Procedure But Prior to Discharge.
Time frame: Predischarge from hospital
Postoperative Toradol
Time frame: Postoperative
Postoperative Anti-emetic
Time frame: Postoperative
Time Between Recovery Initiation and Discharge
Time frame: hours between recovery initiation and discharge
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 24288154Fergusson RJ, Lethaby A, Shepperd S, Farquhar C. Endometrial resection and ablation versus hysterectomy for heavy menstrual bleeding. Cochrane Database Syst Rev. 2013 Nov 29;(11):CD000329. doi: 10.1002/14651858.CD000329.pub2.
- Background: PubMed 19896596Glasser MH, Heinlein PK, Hung YY. Office endometrial ablation with local anesthesia using the HydroThermAblator system: Comparison of outcomes in patients with submucous myomas with those with normal cavities in 246 cases performed over 5(1/2) years. J Minim Invasive Gynecol. 2009 Nov-Dec;16(6):700-7. doi: 10.1016/j.jmig.2009.06.023.
- Background: PubMed 14511961Wallage S, Cooper KG, Graham WJ, Parkin DE. A randomised trial comparing local versus general anaesthesia for microwave endometrial ablation. BJOG. 2003 Sep;110(9):799-807.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jordan Klebanoff, MD principal investigator
Christiana Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bupivacaine and Normal Saline in people with Postoperative Pain, run by Christiana Care Health Services at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Aug 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative Pain Score (time frame: Immediate postoperatively through 8 hours post operation.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02660918, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2019.